International safety notice
At an overseas manufacturer, some lots of "IntellaNav StablePoint Ablation Catheter" may contain The sterile packaging may be damaged if the IFU (medical device instruction manual) enclosed with the unit is placed in the wrong position. It has been confirmed that this is possible. The company has decided to voluntarily recall certain lots of this product.
Japan / PMDA Recalls · JPN · Mar 24, 2023
Key facts
| Title | At an overseas manufacturer, some lots of "IntellaNav StablePoint Ablation Catheter" may contain The sterile packaging may be damaged if the IFU (medical device instruction manual) enclosed with the unit is placed in the wrong position. It has been confirmed that this is possible. The company has decided to voluntarily recall certain lots of this product. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Cardiovascular catheter for ablation Brand name: IntellaNav StablePoint ablation catheter |
| Manufacturer | Boston Scientific Japan Co., Ltd. |
| Models | 84335586, 84644797, 87751644, 87874341, 87852692, 87717510, 86018277, 88117375, 85036118, 85243662, 84771077, 87710789 and 7658 more |
| Date | Mar 24, 2023 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models in FDA data
- 1–9 Matching catalog numbers in FDA data
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About International device safety notices
Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.
Source: National medical device regulators (as listed), compiled by Orca1